Robotic Sedation System Prompts Safety Concerns

Robotic devices are a staple in many hospital operating rooms, though robotic surgery can carry risks to patient safety. Now anesthesiologists are raising concerns about a new robotic device used to sedate patients having colonoscopies.

Johnson & Johnson, the parent company of Ethicon Endo-Surgery, Inc., recently announced that it will soon introduce the computer-assisted device, which is designed to administer propofol without an anesthesiologist. The system is called the Sedasys™. The U.S. Food and Drug Administration approved the machine in May.

Every year more than $1 billion is spent on anesthetic procedures for patients undergoing colonoscopies for cancer screening.  According to Johnson & Johnson, hospitals that install the Sedasys™ device stand to save a significant amount of money by offering colonoscopies with propofol sedation, without requiring an anesthesiologist to administer the drug.

Increased Use of Propofol As Sedative for Colonoscopies

Propofol is common in operating rooms, where it is used to induce patients into general anesthesia. The drug gained public notoriety in 2009 when Michael Jackson died after using the drug at home for problems with sleep. In recent years, use of the drug as a sedative in colonoscopies has increased. Advocates of this use of propofol argue that the benefits of using the powerful drug will encourage patients to undergo the cancer screening procedure. Others argue that using propofol in colonoscopies has increased the rate of complications, along with cost.

Anesthesiology can be the most expensive part of a colonoscopy, when propofol is used. Anesthesiologists charge $600 to $2,000 for their part in colon screening procedures, according to The Wall Street Journal. When other medications are used, an anesthesiologist is not usually required.

Johnson & Johnson says Sedasys™ would cost about $150 per procedure, including all costs except the sedating drug propofol. Hospitals would not have to buy the machine outright. They would simply pay every time they use it.

Johnson & Johnson insists that the device is safe. During testing on more than 1,700 patients, there was not a single incident where a rescue was necessary.

Serious Concerns Expressed about Safety of Sedasys™

Anesthesiologists have voiced serious concerns about the safety of the device. According to comments the American Society of Anesthesiology (ASA) submitted to the FDA, there is limited published research to establish a safety record for the new device, which administers the propofol and monitors a patient’s level of consciousness. While the reported testing of the machine indicated no physician interventions were necessary for patients hooked up to Sedasys™, the ASA noted that each of the clinical trials reported a significant number of patients experiencing complications, including abnormally low levels of oxygen in the blood, apnea, and over-sedation.

The ASA said there are risks of anesthesia errors from the machine’s use of propofol because of the inability of Sedasys™ to prevent or manage a loss of consciousness. Patients sedated with propofol may experience cardiac arrest and need emergency treatment. If an anesthesiologist is not present in the room when the machine is used, there may be little way of detecting problems in time and responding to prevent serious patient harm.

The medical malpractice lawyers at Morrow Kidman Tinker Macey-Cushman, PLLC represent victims of medical negligence in Seattle and across Washington.

Sources:

• American Society of Anesthesiologists
• The Wall Street Journal